IRB: External Collaborations and Reliance Agreements
When researchers from different institutions conduct collaborative human subjects research, it is possible for IRB to lead the review and approval process. A reliance agreement (sometimes called an institutional authorization agreement [IAA] or deferral) must be completed with another appropriately constituted IRB to document the arrangement. Each site must have record of any local context of the research and agree on their roles. PIs and research teams do not make these arrangements without the involvement of both HRPP/IRBs.
Note that some research sponsors and grant agencies may require an IRB of record and request information about the proposed arrangement during a proposal submission or prior to issuance of an award. Please make these considerations during proposal preparation. For guidance on specific NIH-based Single IRB (sIRB) requirements, see this link.
All reliance agreements are established on a case-by-case basis. The Purdue HRPP does not enter into reliance agreements for the following protocols:
- Exempt research (unless determined to require Limited review under applicable exemption categories.) Each institution must follow their own practices for exemptions.
- Development Only/Just-in-time applications that lack definite plans for the involvement of human subjects at the time of protocols submission.
- International research is handled on a case-by-case basis, please see here for guidance.
- Projects where Purdue researchers are not considered engaged in human subjects research.
- Examples of engagement: A site is considered engaged in human subjects research when researchers Interact or intervene with human subjects, perform the informed consent process, obtain personally identifiable data or biospecimens, or are considered engaged by funding regulations (Example: NIH Single IRB Policy.)
Submitting Requests for Reliance
The Purdue IRB may serve in one of these two roles for a reliance/deferral arrangement:
| Reviewing IRB | Relying IRB |
|---|---|
|
IRB determined to have the authority to review and oversee the collaborative research project. Also called the IRB of Record, single IRB (sIRB), lead IRB. |
The IRB whose human research protection program (HRPP) has agreed to cede review of a collaborative research project to the reviewing institution(s). |
Tips to Help Determine a Reviewing or Relying IRB
Purdue HRPP requires a submission in the Cayuse system. Requests for reliance are specific to a single project or protocol. Do not begin the Human Subjects Research activity until a reliance agreement is finalized with each site. Here are points that should help with the process.
- Consider any research-related risks to the participant population and the site where those risks could most likely be mitigated or controlled. If one institution will be responsible for the interactions with participants or housing of identifiable data, it’s a good starting point to consider this as the reviewing IRB.
- Do not submit IRB reliance agreement requests solely on the basis of budget-related matters. Please consider potential external review costs during establishment of the project proposal. Budget related questions should be directed to Purdue Sponsored Program Services. In some cases, the site of the Reviewing IRB and lead (prime) institution on a grant differ.
- Utilize this flowchart to help define each investigator or coordinator’s role at a site and the necessary documents for submission in each case.
- For multisite studies where each investigator has the same role, consider the impacts of the research team’s expertise or data collection and storage practices that might make one site most qualified to lead.
- Review the entire research team and their engagement in the research. For example, if a site is not interacting or intervening with human subjects (recruiting, consenting, collecting identifiable specimens, etc.), it is unlikely that the site’s IRB should serve as the Reviewing IRB.
Purdue as the Reviewing IRB
The investigator at the external site (outside Purdue) may need to initiate an IRB notification process at their home institution. Addition of external personnel to a Purdue protocol should be initiated after the external investigator has consulted with their IRB. This is often the source of delay if not considered in advance.
The external collaborator/site will be added to the Purdue protocol in Cayuse IRB either in the initial study submission or as a modification to an existing study.
Information needed about the relying site personnel:
- External Personnel contact information including their email and work phone number
- External Personnel role(s) in the study: (e.g. interacting or intervening with participants, consenting participants, analyzing identifiable data.)
- Documentation from the External Personnel’s IRB that they may be willing to cede review to Purdue’s IRB. Institutions vary in how this is provided (e.g. e-mail, signed document, memo.
Reliance agreements are utilized for research reviewed under the Full, Expedited, and Limited categories. Reliance agreements for exempt research are not required. If the study has been exempted by the Purdue IRB, then the external collaborator should work with their IRB to determine the institution-specific requirements for their role in the research.
Purdue as the Relying IRB
Submit information in Cayuse.
Upload the following documents in the Cayuse submission when prompted.
- Approval or status memo from the Reviewing IRB
- Reviewing IRB protocol and consent form(s); these can be obtained from the external collaborator
- Any consent form(s) to be used by Purdue researchers
- Reliance documents, or other forms provided by the Reviewing IRB, if applicable
HRPP staff will review the request for reliance and work with the requested reviewing IRB to complete the agreements.
For Purdue University collaborative exempt research, if a study is exempted by another IRB, then submit a new request for exemption in the Cayuse system.
Follow these steps to submit a request to defer/rely on another IRB.
Examples (each example is hypothetical, intended for guidance purposes only)
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For a collaborative research project, a Purdue researcher plans to receive tissue specimens from a medical study conducted at Sample Medical College in the US. All research conducted with human subjects will occur at Sample Medical College, but most samples and data will be sent to Purdue for specialized analysis.
In this case, the IRB of record should be the Sample Medical College IRB. The Purdue PI should submit a request for reliance in the Cayuse system. Within the body of the application, the researcher will be asked for their role on the study, contractual agreements for data/specimen transfer and protection (through Purdue University Sponsored Program Services), training verifications, and questions related to any identifiers or data provided to them.
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A Purdue researcher would like to conduct research activities to study how elementary students learn a new math curriculum in the classroom. The Purdue research team will develop the study instruments and serve as the recipient of an externally-funded award. The Purdue team will work with an investigator from another university to develop the curriculum and each will work with local schools to assess the curriculum.
It’s likely that either IRB could serve as the Reviewing IRB for the research. The bulk of development of study instruments may be an indicator of a site that could serve as a Reviewing institution. Both study teams will need to provide permission from the schools they will work with to access the sites. If there is not a distinct requirement from the sponsor for one IRB, it is also reasonable for both sites to conduct their own IRB review to address the local items, accesses, or regulations applicable for the state or school system. Recall, that if the research is exempt, an agreement is not necessary. Each investigator should consult with their respective IRB for assistance.
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A Purdue investigator would like to join the research study team at another university. IRB approval has been established for several years and the Purdue investigator would like to examine the data for secondary analysis.
Unless the Purdue investigator is taking a role in the primary research question at the other institution, it’s likely that the best solution is to submit an application for secondary data analysis (Exemption Category 4). This can be accessed in the Cayuse system. Note: the transfer of identifiable data may involve a requirement for agreements between the two institutions. This is handled through Purdue University Sponsored Program Services.
Additional Information
Clarification for Common Terms
IRB Authorization Agreement (IAA)/Reliance Agreement/Deferral Agreement – a written agreement between IRBs when one IRB is acting as the IRB of record and the other is ceding review to that IRB.
FWA – Federalwide Assurance – an assurance of compliance that an institution commits to HHS that it will comply with the Common Rule 45 CFR 46. An institution must have an FWA to receive US federal funds for human subjects research. An FWA is a number that represents an institution and is separate from an IRB protocol number. Purdue University’s FWA is FWA00001548.
SMART IRB – a reliance platform and system and accompanying master reliance agreement that have been accepted by all participating members. Purdue is a participating institution to the SMART IRB platform and it is our preference to use SMART IRB when possible. However, PIs must first submit the request in the Cayuse system and the office staff will provide guidance on next steps.
Accreditation Status – The Purdue University Human Research Protection Program is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Federal Policies Requiring the Use of a Single IRB
Beginning January 20, 2020, the revised Common Rule requires that institutions in the US that are engaged in cooperative research conducted or supported by a Common Rule department or agency must rely upon a single IRB for non-exempt research. This does not apply to international research or exempt research.
This policy applies to NIH-sponsored, domestic, multi-site studies, where the same protocol is used at multiple sites for non-exempt research.
